2017 Florida Vascular Society

Transcription

1 Current Management of Venous Leg Ulcers: How to Identify Patients with Correctable Venous Disease and Interventional Procedures to Heal and Prevent Recurrence 2017 Florida Vascular Society Bill Marston MD Professor and Chief, Div of Vascular Surgery University of N. Carolina

2 Disclosures Veniti Inc. Consultant Tactile Medical Investigator Cardinal Healthcare Consultant Factor Therapeutics Investigator

3 Vein Clinics

4 What do vein clinics want to do?

5

6 Exponential increase in PTS and other patients with severe CVI

7 Chronic nonhealing leg ulcer 52 YO male w h/o multiple DVTs starting 11 yrs before initial visit in both legs Prot C deficiency Bilateral edema, worse on L Ulceration on left Unable to work due to symptoms

8 Venous diagnostics VEIN EXAMINED Common Femoral Vein Superficial Femoral Vein Popliteal Vein Great Saphenous (SFJ) Great Saphenous (knee) Small Saphenous LEFT 2.45 sec 2.81 sec 3.22 sec 1.68 sec 5.03 sec 0.11 sec CFV compressible FV, Pop partially compressible GSV 6-8 mm diameter APG: VFI 12.7 cc/sec 8

9 Duplex of CFV Common femoral vein waveforms studied for evidence of iliac obstruction

10 Rx protocol for VLU 1 Elimination of venous HTN Compression Correction of venous insufficiency 2 Wound debridement 3 Bacteria control 4 Exudate control 5 Adjuvant therapies to accelerate closure

11 Venous insufficiency causes tissue inflammation Chronic upregulation of proteases pro-inflammatory cytokines Tissue fibrosis, ulceration, poor healing Healing associated with reduction in these levels

12 What does this have to do with treating a VLU? To be successful we must: Diagnose whether this leg ulcer is due to venous disease Eliminate venous hypertension Control edema Remove wound fluid from contact with skin and tissue because of destructive proteins and enzymes in fluid

13 How can we treat venous disease to eliminate edema and improve healing? Stimulate improved venous drainage Increase use of calf muscle pump External compression Compression stockings Bandaging, etc Correct underlying venous disorder Eliminate obstruction Correct or eliminate refluxing veins Implant new functional valve into abnormal vein

14 Compression therapy: Options

15 Randomized trial of 4-layer elastic compression (Profore) versus Unna s paste boot 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 74% 24 weeks 66% 68 patients Profore Unna Polignano et al, J Wound Care 2004;13:21-4

16 Venous leg ulcer recurrence after healing Follow-up data in 110 patients after ulcer healing Recurrent ulceration developed in: 24% of limbs within 1 year 33% of limbs within 2 years 49% of limbs within 5 years Marston et al J Vasc Surg 1999;30:491-8

17 Venous Anatomy in VLU patients Anatomic distribution of venous reflux in 138 limbs with leg ulcer: Deep alone 43.5% Deep and superficial 21.0% Deep, perforator and superficial 6.5% Superficial alone 18.1% Superficial and perforator 10.9% Owens et al, J Vasc Surg 2000

18 Endovenous ablation 30% of VLU patients can be corrected with superficial and/or perforator ablation

19 Lancet 2004;363:

20 Eschar study: Results Ulcer healing 24 week ulcer healing rate 65% in compression group 65% in compression plus surgery grp 3 year healing rate 89% in compression group 93% in compression plus surgery grp week 3 year compress ion compress ion plus surgery

21 Eschar Results: Ulcer Recurrence 48 month ulcer recurrence rate 51% in compression group 27% in compression plus surgery grp P<0.01 % ulcer recurrence Compr Compr + surg

22 UNC Study on saphenous ablation in venous ulcer patients: Goals Determine the incidence of ulcer healing after EVLA for saphenous insufficiency Determine the incidence of ulcer recurrence after EVLA for saphenous insufficiency

23 Results: Patient population 162 limbs Active ulcers (Class 6) n=67 (41%) Healed ulcers (Class 5) n=95 (59%) Females n=95 (59%) Median age 58.5 Deep venous insufficiency n=47 (29%)

24 Procedure performed GSV ablation n=138 SSV ablation n=17 Both GSV and SSV ablation n=7 # of veins ablated per limb 1.1 phlebectomy w EVLA 35% Median patient follow-up 15 months

25 % of ulcers healed a er EVLA 84% 77% 3 months 6 months 12 months 18 months

26 35 % ulcer recurrence a er EVLA % 20 23% % 16% 1 year 2 years 3 years 4 years

27 Risk factors related to ulcer recurrence at 2 years Risk Factor # limbs Recurrence Hazard Est P value Deep reflux Yes 47 32% No % Phlebectomy Yes 56 15% No %

28 Other options to eliminate saph veins Foam sclerotherapy Mechanico-chemical ablation (MOCA) Glue Steam Other

29 Peri-ulcer foam sclerotherapy

30 Local injection of peri-ulcer Ultrasound guidance critical in many cases veins Identify path of superficial varicosities extending down to wound area 1% STS foam or Varithena

31 Local injection for VLU Bush, RL Persp Vasc Surg 2010;22:294-9 Eliminate all local sources of venous HTN 1% STS foam injection in venous branches around ulcer 14 of 14 ulcers healed at avg of 6-8 weeks

32 Venous outflow obstruction

33 78 patients with CEAP clinical class 5 or 6 CVI identified at a multispecialty wound healing center All tested with CT or MR venography to determine incidence of ilio-caval obstruction Marston W, Fish D, Unger J, et al, Incidence of and risk of factors for iliocaval venous obstruction in patients with active or healed venous legulcers. J Vasc Surg 2011 May;53(5):

34 Incidence of ilio-caval obstruction on CT/MR Iliocaval stenosis % of total cases 100% 8.8% 80-99% 14.0% 50-79% 14.0% 30-49% 5.3% 10-29% 17.5% 0-10% 42% 80% 23% 50% 37% Marston W, Fish D, Unger J, et al, Incidence of and risk of factors for iliocaval venous obstruction in patients with active or healed venous legulcers. J Vasc Surg 2011 May;53(5):

35 Risk factors associated with increased incidence of ICVO Risk Factor ICVO with ICVO w/out p Val risk factor risk factor Age > % 21.2%.89 Diabetes mellitus 29.4% 20.9%.43 African American 31.2% 20.5%.37 Left limb ulcer 30.8% 16.1%.16 BMI > % 12.0%.09 Female gender 33.3% 12.9%.06 History of DVT 37.9% 7.1%.005 Deep venous reflux 39.8% 0%.002 Marston W, Fish D, Unger J, et al, Incidence of and risk of factors for iliocaval venous obstruction in patients with active or healed venous legulcers. J Vasc Surg 2011 May;53(5):

36 Iliac v. obstruction: Diagnosis

37 Utility of CFV duplex as a % iliac stenosis on CT/MR screening test % of duplex exams negative for ICVO % of duplex exams positive for ICVO < 50% 100% 0% 50-79% 100% 0% 80% 23% 77% Sensitivity - 77% Specificity - 100% 37

38 Thin cut 3D CT or MR venography 1 mm cuts Examined in multiple planes Max % of narrowing of iliac or IVC recorded

39 Venography and IVUS: Definitive but invasive

40 Technical performance of intervention for ICVO

41 Diversity of iliocaval obstruction Type 1 Type 4

42 DUS guided femoral vein access

43 Requirements of venous crossing system (not arterial) Long stiff sheath for support 5F for initial cross then 8F to accommodate IVUS Guiding catheter Stiff glide or stiff tipped TCO wire Keep components close together for support Capability for frequent injection to confirm intraluminal position

44 Triaxial Crossing system Stiff Tungsten coated 5F sheath that tapers to 4F at tip Angled guiding catheter Favorite crossing wire But don t lead far out of sheath Can inject through port with system intact

45 Understand anatomy

46 Extraluminal adventures They happen Usually not associated with significant retroperitoneal hematoma

47 Once wire across lesion Dilate with small balloon and inject to be sure no extravasation Sequentially dilate to large diameters and stent Options for handling iliac confluence

48 Use of IVUS to identify normal vs compressed vein Normal vein Compressed vein

49 Full dilation of outflow tract CIV = 200 mm 2 -Need 16 mm stent EIV= mm 2 -Need 12 mm stent

50 Special considerations JVS 2008;48:1255 Stent can be extended inferiorly into CFV without high risk of /recurrent thrombosis Stent fractures may occur Do they matter in the venous system?

51 Stent design for the venous system Current stent designs Inadequate strength Excessive shortening Prone to migration Inadequate lengths requiring multiple stents Stent hyperplasia

52 Novel venous stents: Design characteristics Nitinol self expanding Closed cell design Increased density No gaps between struts Increased strength with little shortening 9F delivery system lengths to 120 mm Diameters 12 to 16 mm 52

53 Current status of venous stent development in US Purpose designed venous stents well into clinical trials to document performance characteristics Results expected Q Comparator: Objective performance goals based on published results Veniti Cook

54 Evidence that iliac stenting improves patient symptoms Symptom Severe leg pain Preinterventio n Postinterventio n P value 54% 11% <.001 Leg swelling 44% 18% <.001 Raju, Neglen; J Vasc Surg 2007;46:979

55 Post ICVO intervention Symptoms improved, less pain with compression Edema control improved Symptom improvement relates to severity of obstruction

56 UNC ICVO intervention in Class 5-6 patients N=47 Median age 47 Median ulcer size 63 sq cm Median ulcer duration 2.2 years 90% post-thrombotic 87% class 3 or 4 21% reintervention rate at 12 months

57 Ulcer recurrence after intervention vs compression n=252 n = 168 n=37

58 VLU mgmt: Summary Optimal management of VLU requires dedicated wound management program and venous specialist Specific tool set and techniques required Can t just apply arterial methods Management of superficial and deep disease required Majority of patients can be improved by superficial ablation, phlebectomy, sclerotherapy or venous stenting

59 Questions